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Publications & Whitepapers

Whitepaper

Dec 19 2025

Navigating your First EU Trial: From First Steps to Compliance

Published on: Dec 19, 2025 Embarking on your first clinical trial in Europe marks an important milestone for any biotech company. Whether your goal is to develop a rare disease treatment, enter a new market, or build a clinical package for global regulatory submission, Europe offers a complex but highly rewarding environment. With its harmonized […]

  • Clinical Trials
  • Europe
  • Vigilance
Whitepaper

Nov 21 2025

Microbiome Innovation One Health Conference Report

Published on: Nov 21, 2025 If there was one clear message from MIOHC 2025, it’s this: the microbiome field has grown up. The excitement remains, but now it’s backed by data. Investors want more than a good story, they’re looking for data powered studies, clear mechanisms and a roadmap to market, whether you’re building a […]

  • Microbiome
Whitepaper

Jan 07 2025

Microbiome Testing in Europe: Navigating Analytical, Ethical and Regulatory Challenges

Published on: Jan 7, 2025 In recent years, human microbiome research has flourished and has drawn attention from both healthcare professionals and general consumers as the human microbiome is now recognized as having a significant influence on human health. This has led to the emergence of companies offering microbiome testing services. Some of these services […]

  • Microbiome
Whitepaper

Jun 08 2023

Regulatory Trends in the Nonclinical Development of Viral Vector-Based Gene Therapies: A Benchmark Analysis of Approved Products

Published on: Jun 8, 2023 As it is often the case with innovative technologies, regulatory agencies are highly demanding in product safety demonstration from those pioneering breakthrough therapy products. Since the first historically approved gene therapy medicinal product (Gencidine in 2003) by the Chinese National Medicinal Products Administration, gene therapy medicinal products have slowly been […]

  • Nonclinical|Regulatory strategy
Whitepaper

Apr 14 2023

Are Registries the New “Gold Standard” ?

Published on: Apr 14, 2023 There are multiple definitions associated with a registry and any future sponsors can feel anxious when it is time to endorse the responsibility of this type of study. Indeed, “Registries” gather not only observational studies at the initiative of one sponsor but also include Post-Authorization Safety or Efficacy Studies (PASS […]

  • Clinical Trials
Whitepaper

Apr 26 2022

CMC considerations for US biosimilars development

Published on: Apr 26, 2022 The US Biologics Price Competition and Innovation Act of 2009 (BPCI Act) provides an abbreviated licensure pathway for biosimilar products. This pathway brought the hope of lower cost biologics, perhaps similar to what was accomplished by generics for small molecule drugs. Twelve years have now passed since the BPCI Act and […]

  • CMC
Whitepaper

Sep 30 2021

IVDR Readiness Checklist

Published on: Sept 30, 2021 In the blog post “IVD Directive to IVD Regulation Transition – 8 months remaining”, my colleague outlined some key focus areas that IVD manufactures should pay attention to, such as classification, Notified Body and QMS, etc. Some key dates are highlighted in the below figure. Despite widespread industry calls to […]

  • Market Access
Whitepaper

Jun 28 2021

Possible Contexts of Use for In Silico trials methodologies: a consensus-based review

Published on: Jun 28, 2021 The term “In Silico Trial” indicates the use of computer modelling and simulation to evaluate the safety and efficacy of a medical product, whether a drug, a medical device, a diagnostic product or an advanced therapy medicinal product. Predictive models are positioned as new methodologies for the development and the […]

  • in silico
Whitepaper

Jun 01 2021

Advanced therapies in the EU: challenges with HTA and real-world evidence

Published on: Jun 01, 2021 Market access aims to make a health technology not only available and affordable for every patient, but also profitable for the company placing it on the market. Indeed, where a health technology is unprofitable, it does not stay long on the market and becomes unavailable to patients. With advanced therapy […]

  • ATMP|Cell &amp
  • Gene Therapy|EMA|Market Access
Whitepaper

Sep 04 2020

Human Microbiomes in Health and Disease: Strategic Options for Regulatory Science and Healthcare Policy

Published on: Sept 4, 2020 This article describes the human microbiota and microbiomes’ strategic role in personalizing health and disease management, which is rapidly demanding diligent regulatory science and policy action to ascertain confidence and trust among consumers, patients, and healthcare providers. The authors discuss why establishing harmonized processes and standards to better understand the […]

  • Microbiome
Whitepaper

Aug 17 2020

General Data Protection Regulation and Patients Enrolled in EU Clinical Trials

Published on: Aug 17, 2020 Processing and cross-border flows of personal data significantly increased over the past decades in the EU, and it became necessary to strengthen the associated legislation. This led the European Commission to adopt the General Data Protection Regulation (GDPR (Regulation (EU) 2016/679) to protect the fundamental right of citizens to privacy […]

  • Clinical Trials
Whitepaper

Jun 23 2020

Clinical Trials with GMOs in the EU – From Regulatory to Sites

Published on: Jun 23, 2020 Clinical trials (CTs) with investigational medicinal products (IMPs) that contain or consist of genetically modified organism(s) (GMO-IMPs) have significantly increased in Europe over the past few years. Initiation of such CTs should comply with both CT and GMO regulatory frameworks and requires applications to various competent authorities (CAs). Coordinating these submissions, […]

  • Clinical Trials
Whitepaper

Apr 03 2020

Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs, Gaps, and Challenges

Published on: Apr 3, 2020 The added value of in silico models (including quantitative systems pharmacology models) for drug development is now unanimously recognized. It is, therefore, important that the standards used are commonly acknowledged by all the parties involved. On April 25 and 26, 2019, a multistakeholder workshop on the validation challenges for in […]

  • Clinical Trials|in silico
Whitepaper

Jan 24 2020

A Regulatory Landscape Shift for In Silico Clinical Trials

Published on: Jan 24, 2020 Modelling and simulation (M&S) has grown to become a reliable approach to better understand and optimize key decisions related to safety, efficacy, dosing, and special target populations. As both computing power and our understanding of human systems biology improve, the increased use of M&S motivates regulators to consider this new […]

  • Clinical Trials|Regulatory strategy
Whitepaper

Sep 09 2019

Recent Revisions to Legislation Impacting the Pharmaceutical Industry in Switzerland

Published on: Sept 9, 2019 With the objective of harmonizing pharmaceutical regulatory practices and legislation with Europe, the Swiss Medicines Agency (Swissmedic) recently conducted an in-depth review of the primary legislation governing the authorisation and lifecycle management of medicinal products in Switzerland. This has resulted in the revision of a number of enacting legal Ordinances, […]

  • Regulatory strategy
Whitepaper

Sep 09 2019

EU Cooperation on Health Technology Assessment and Beyond

Published on: Sept 9, 2019 An informative session at this year’s DIA meeting gave an overview of the European Commission’s proposal for mandatory centralization of HTAs, together with an update on the initiative which provides for joint HTA and pricing negotiations between the five Beneluxa countries. To stimulate cooperation between health technology assessment (HTA) bodies […]

  • Market Access
Whitepaper

Aug 08 2019

Optimising the Choice of the Condition for a Paediatric Investigation Plan

Published on: Aug 8, 2019 The “Condition” is typically a recognised distinct disease or syndrome that is the subject of a paediatric investigation plan (PIP) and/or waiver application required for most new, and some authorised, medicinal products in the EU. Its scope defines the disease(s) that must be covered by, or that may be excluded […]

  • Regulatory strategy
Whitepaper

Jul 07 2019

Evolution of the European Regulatory Framework for Innovation – Key Topics for the Future

Published on: Jul 7, 2019 DIA Europe 2019 was held this year in Vienna, Austria. Speakers included national regulators, together with representatives from health technology assessment (HTA) bodies, patient advocacy groups, and other critical stakeholders. Presentations covered the entire healthcare value chain, ranging from policy and regulations to research and development, marketing and access. In […]

  • EMA|Regulatory strategy
Whitepaper

Mar 10 2019

AMR: Is a Paradigm Shift Needed in Medicines

Published on: Mar 10, 2019 Antimicrobial resistance (AMR) is the ability developed by bacteria, viruses, parasites or fungi to fight and block the effect of antimicrobials including antibiotics, antivirals and antiparasitics that were developed to kill or control their growth. AMR is a global public health problem presenting a continually increasing threat on human and […]

  • Orphan &amp
  • Rare Disease|Regulatory strategy
Whitepaper

Feb 01 2019

Expedited access of cellular and gene therapy products: The EU versus the US

Published on: Feb 1, 2019 There is some variation in the eligibility criteria and features of breakthrough therapy designation (BTD), regenerative medicine advanced therapy (RMAT) designation, and the PRIority MEdicines (PRIME) scheme, as will be explained in this review. The expectations that the FDA and the EMA have for RMAT and PRIME, respectively, are distinct […]

  • Cell &amp
  • Gene Therapy
Whitepaper

Oct 02 2018

Brexit: The legal and regulatory impact on supply chain and pharmacovigilance

Published on: Oct 2, 2018 The UK will withdraw from the EU on 29 March 2019. By 1 August 2018, no agreement had been reached on a transitional arrangement to soft en the impact of Brexit. The European Commission and the European Medicines Agency (EMA) have taken a strict position on Brexit, considering the UK […]

  • Regulatory strategy
Whitepaper

May 28 2018

Cell and Gene Therapies: Addressing the Challenges in Translation

Published on: May 28, 2018 Advanced therapy medicinal products (ATMPs), i.e., cell and gene therapy products, is a rapidly evolving field of therapeutic development. A significant proportion of the products are being developed by academia or small/medium-sized enterprises (SMEs). The many challenges in translation posed by this class of products include aspects covering: manufacturing, non-clinical […]

  • Cell &amp
  • Gene Therapy|Regulatory strategy
Whitepaper

May 23 2018

Market Access for ATMPs Begins at the Bench

Published on: May 23, 2018 Despite their significant therapeutic potential, ATMPs face specific market access challenges compared to other therapeutic categories. These include high manufacturing costs, incremental benefit claims that extend over an extended time frame, restriction to centres of excellence and disruption of existing service delivery processes, often requiring significant reallocation of healthcare resources. […]

  • Cell &amp
  • Gene Therapy|Market Access
Whitepaper

May 08 2018

Public Access to Clinical Data: The evolution of initiatives from the European Medicines Agency

Published on: May 8, 2018 It remains the mission of all stakeholders to get high quality medicines to patients as time- and cost-efficiently as possible. To facilitate this process, the EMA has taken a number of initiatives to make clinical data, submitted to support marketing authorisations, increasingly available to industry and the general public alike. […]

  • EMA
Whitepaper

Mar 06 2018

The First 10 Years of the European Paediatric Regulation

Published on: Mar 6, 2018 The conference, organized by TOPRA in collaboration with the European Commission (EC), was the opportunity to hear about the EC’s 10-year review report to the European Parliament and the Council. The report provides an account of the paediatric regulation’s achievements, both in public health and economic terms 10 years after […]

  • EMA|Regulatory strategy
Whitepaper

Feb 02 2018

Challenges in Conducting Clinical Trials in Rare Diseases

Published on: February 2, 2018 While individually rare, orphan diseases collectively are actually quite common, with an estimated 350 million sufferers worldwide. Since the introduction of the Orphan Drug Act in the US more than 30 years ago, followed by legislation in Japan in the 1990s, and the EU Regulation on Orphan Medicinal Products in […]

  • Clinical Trials|Orphan &amp
  • Rare Disease
Whitepaper

Jan 25 2018

Clinical trials with ATMPs in Europe: a focus on GMO specificities

Published on: Jan 25, 2018 Advanced Therapy Medicinal Products (ATMPs) are an innovative type of medicines for human use, based on genes, cells or tissues. The multiplicity of clinical studies involving ATMPs and more especially GMO products has brought us to focus on the specific requirements for these type of clinical trials.The aim of this […]

  • Cell & Gene Therapy
  • Clinical Trials
Whitepaper

Oct 02 2017

In Silico Approach: from computer to patient ?

Published on: Oct 2, 2017 Until recently, all pharmacology characterization was involving in vitro and in vivo studies. Important efforts arebeing made to refine in vitro and animal models to ensure better translation to human physiology in health and disease. Today, drug discovery faces however rising numbers of new molecules to evaluate vs. increasing costs […]

  • Clinical Trials
  • in silico
Whitepaper

Jul 07 2017

Integrating the Paediatric Population within Global Drug Development

Published on: Jul 7, 2017 By setting mandatory requirements, paediatric regulations implemented in the EU and the US have allowed the development of – and improved access to – high-quality drugs for the paediatric population. It is acknowledged that paediatric development remains a challenge in many circumstances and, ten years after the implementation of the […]

  • EMA|Regulatory strategy
Whitepaper

Jul 03 2017

Overcoming Regulatory and CMC Technical Challenges of Microbiome Product Development

Published on: Jul 3, 2017 In this white paper we provide a fleeting look at some of the CMC ‘building blocks’ that can be assembled for moving a microbiome product from R&D into first into human studies.

  • CMC
  • Microbiome
  • Regulatory strategy
Whitepaper

Jun 01 2017

Advanced Therapy Medicinal Products: An Innovative and Collaborative Approach

Published on: June 1, 2017 Advanced therapy medicinal products (ATMPs) belong to a rapidly developing, state-of-the-art field of science and technology in the EU. Due to the complex nature of ATMPs involving gene and cell therapy products, product development can be challenging. Regulatory approval and the final commercial reimbursement needed for an adequate return on […]

  • Cell &amp
  • Gene Therapy
Whitepaper

Jun 01 2017

Early Access Programmes / Compassionate Use Programmes: How to effectively deal with the challenges

Published on: Jun 1, 2017 Early access programmes (sometimes also called compassionate use or temporary use authorisation) were set up because of the rapid advances in science and the legitimate expectations of physicians or patients for early access to unauthorised medicinal products prior to marketing authorisation and commercial launch (with the assumption that a favourable […]

  • Clinical Trials
  • Orphan & Rare Disease
Whitepaper

May 17 2017

Navigating the Maze of m-Health Regulation and Development

Published on: May 17, 2017 The widespread adoption of mobile and wireless technologies, including smartphones and tablets, has given rise to the growing field of mobile health (m-Health) which is poised to revolutionize sectors of healthcare. The rapid pace of growth in m-Health presents developers with key challenges in designing and implementing new mobile solutions. […]

  • Digital Health
  • Regulatory strategy
Whitepaper

May 08 2017

Overcoming the Challenges of Establishing Expanded Access Programs in European Member States

Published on: May 8, 2017 Early access programs (EAP) provide unauthorized medicinal products prior to marketing authorization and commercial launch for life-threatening, chronically or seriously debilitating diseases, which can not be treated satisfactorily by an authorized medicinal product. Legislation is mostly at the national level, and practical aspects such as conduct, sponsorship, permission to charge […]

  • Clinical Trials
Whitepaper

Feb 02 2017

Considerations for Developing EU Risk Management Plans

Published on: February 2, 2017 This article aims to share some key considerations when defining the strategy for the preparation of a risk management plan (RMP). The RMP is required to be submitted when applying for an EU marketing authorisation application (MAA). Advice is offered to applicants and medicinal product developers to maximise the utility […]

  • Vigilance
Whitepaper

Jul 07 2016

Obtaining Orphan Status – A key milestone within a development strategy

Published on: Jul 7, 2016 This article describes the regulatory frameworks and incentives associated with orphan drug designation (ODD) in the EU and the US, as well as capturing key strategic considerations needed to achieve successful orphan drug product development and registration in both regions.

  • Orphan &amp
  • Rare Disease|Regulatory strategy
Whitepaper

Apr 01 2016

Market Access in Europe: Bridging Regulatory and Health Technology Assessment (HTA) Gaps

Published on: Apr 1, 2016 This article introduces the roles of HTA bodies within the EU member states healthcare system and provides key elements to consider for manufacturers, which would like to enter such geographical market, on key elements to consider. In addition solutions to maximize the product development strategy are discussed, with the intention […]

  • Market Access
Whitepaper

Jun 08 2015

Preparing a Drug Registration for the US and the EU Parallel or sequential applications – Part 2

Published on: Jun 8, 2015 This article, the second in a two part paper highlights the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation. June 2015 – Regulatory Rapporteur

  • EMA|FDA
Whitepaper

May 05 2015

The Challenges of Potency Assay Development for Cell-based Medicinal Products in Europe

Published on: May 5, 2015 Developing the relevant set of potency assays for cell-based medicinal products comes with numerous challenges due to the complex nature of the products. This paper highlights several approaches to consider when designing the potency assay strategy in the framework of current EU regulatory expectations. Valerie Pimpaneau, François Gianelli, Anne Dupraz […]

  • Orphan &amp
  • Rare Disease
Whitepaper

Mar 11 2015

Keeping Up with Innovation The challenge for regulators

Published on: Mar 11, 2015 Big data, mobile health and synthetic biology: An overview of some of the changes and measures were taken by regulators as they strive to keep up with the latest developments. Habib Zalila and Emmanuelle Voisin This article was published in Scrip Regulatory Affairs on 11 March 2015

  • Regulatory strategy
Whitepaper

Mar 02 2015

Modern Technology Transfer Strategies for Biopharmaceutical Companies

Published on: Mar 2, 2015 Application of industrial biotechnology has changed dramatically over the past decade. Stainless steel process equipment has largely given way to disposable systems, facilitating easier and quicker process configurations and up-scaling. Suppliers generally made incremental advances in the quality of raw materials and consumables to ensure that those could more readily […]

  • Digital Health
Whitepaper

Feb 02 2015

Preparing a Drug Registration for the US and the EU: Parallel or sequential applications? – Part 1

Published on: Feb 2, 2015 An overview of the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation. Nathalie Boeglin, Alice Rolland, Frederic Pailloux and David Uguen. February 2015 – Regulatory Rapporteur Click here for Part 2

  • EMA|FDA
Whitepaper

Oct 01 2014

Regulatory Approval and Market Access: a winning combination for drug launch optimization

Published on: Oct 1, 2014 Having a combined regulatory and market access strategy is critical for a drug launch to be successful. Marcus Deans, Mark A De Rosch and Emmanuelle Voisin

  • Market Access|Regulatory strategy
Whitepaper

Feb 10 2014

Accelerating development, registration and access to medicines for rare diseases in the European Union through adaptive approaches features and perspectives

Published on: Feb 10, 2014 Accelerating development, registration and access to medicines for rare diseases in the European Union through adaptive approaches: features and perspectives There is growing recognition that the current research-and-development (R&D) and innovation-regulation ecosystem could be made more efficient to stimulate and support access to innovative therapies for those patients with rare, […]

  • Orphan &amp
  • Rare Disease|Regulatory strategy
Whitepaper

Sep 30 2013

Clinical Trials in the EU/EEA: focus on CMC aspects

Published on: Sept 30, 2013 Clinical Trials in the EU/EEA- Focus on CMC Aspects Clinical trials testing the Benefit/Risk ratio of Investigational Medicinal Products (IMPs) in the European Union/European Economic Area (EU/EEA) are governed currently by Directive 2001/20/EC. This has led to different requirements amongst the Competent Authorities (CAs) and Ethics Committees (ECs) of each […]

  • Clinical Trials
Whitepaper

Jul 01 2013

Current Clinical Trial Scenario of India

Published on: Jul 1, 2013 The Indian Clinical Trial Industry, considered as the booming sector and perceived as a potentially upcoming segment, is undergoing turmoil today with a decline of 9.60 per cent in revenues, with further decline because of delay/decreased clinical trial approvals. Rajashree Devarakonda 2013- Pharma Bio World

  • Clinical Trials
Whitepaper

Jul 01 2013

The Proposed EU IVD Regulation and its Impact on Companion Diagnostic Development

Published on: Jul 1, 2013 Stricter rules are in store for CDx stakeholders in the EU but it’s not all bad news. Sylvie Le Glédic, Sabah Malek 2013 – SCRIP Regulatory Affairs

  • Medical device|Regulatory strategy
Whitepaper

Oct 15 2012

Development of orphan products and the impact of the EU Paediatric Regulation, TOPRA Vol 9, No.10

Published on: Oct 15, 2012 Development of orphan medicinal products (OMPs) is challenging by nature: knowledge is usually limited; the patient population are small and often frail; and the implementation of the Paediatric Regulation in the EU has added a layer of complexity, especially for OMPs. Marie Deneux, Séverine Marconi, David Uguen 2012 – Regulatory […]

  • EMA|Regulatory strategy
Whitepaper

Oct 10 2012

Nutraceuticals and functional food regulations in key emerging markets

Published on: Oct 10, 2012 Nutritionals & Nutraceuticals describe the group of products occupying the grey zone between food and medicines and having recognisable health and physiological benefits attributable to the efficacy of their consumption. In the more developed markets, these products have increasingly experienced more stringent regulatory controls for the primary reasons of product […]

  • Microbiome|Regulatory strategy
Whitepaper

Oct 01 2012

Designing a CMC Strategy For Advanced Therapy Medicinal Products (ATMP) in EU

Published on: Oct 1, 2012 Valerie Pimpaneau and Anne Dupraz Poiseau discuss the latest EU guidelines on ATMPs and explain how to develop a solid chemistry, manufacturing and control strategy for such products. Valérie Pimpanneau, Anne Dupraz-Poiseau 2012 – SCRIP Regulatory Affairs

  • Cell &amp
  • Gene Therapy|Regulatory strategy
Whitepaper

Jul 04 2012

Quality by Design: a beginner’s guide

Published on: Jul 4, 2012 Quality by design (QbD) is becoming increasingly utilized as a valuable tool for focused and efficient drug development. Centering on case studies, we will look at how QbD can be used in its application to small molecules and biopharmaceuticals. Florence Philippoz, Richard Dennett 2012 – STP Pharma Pratiques

  • Regulatory strategy
Whitepaper

May 01 2012

Applying for Multinational EU Trials Can be Faster via Voluntary Harmonisation Procedure (VHP)

Published on: May 1, 2012 Using the voluntary harmonisation procedure to apply for permission to conduct multinational clinical trials across the EU can, in some cases, lead to faster trial authorisations, compared with using the traditional application approach. Neena Brizmohun, stating Delphine Decker 2012 – SCRIP Regulatory Affairs

  • Clinical Trials
Whitepaper

Feb 20 2012

Hybrid or Mixed Marketing Authorization Application in the EU: not a trivial decision in new development programs for established drugs

Published on: Feb 20, 2012 For any medicinal product Marketing Authorization Application (MAA) in the European Union, the applicant needs to indicate the legal basis for the application. This legal basis, laid down in Directive 2001/83/EC as amended, determines the dossier content, the market exclusivity, and the pediatric requirements in a significant way. Andreas VogelHybrid […]

  • EMA|Regulatory strategy
Whitepaper

Feb 07 2012

US & EU Regulations for Drug Delivery Systems: development considerations for innovate products

Published on: Feb 7, 2012 Marielle Fournier and Anne Dupraz-Poiseau describe US and EU rules governing prefilled syringes, pen injectors and innovative drug-delivery systems for biologics and consider the safety, quality and efficacy development challenges for manufacturers. Anne Dupraz-Poiseau, Marielle Fournier

  • FDA
Whitepaper

Nov 01 2011

Biomarkers qualifications: a first step towards companion diagnostic development

Published on: Nov 1, 2011 Biomarker qualification can be a first step towards companion diagnostic development. The European Medicines Agency already has a biomarker qualification process and the US Food and Drug Administration is developing one itself. The two agencies should find a way to harmonise their respective processes and propose clear incentives for companies […]

  • Medical device
Whitepaper

Oct 10 2011

Considerations on Pediatric Investigation Plans (PIP) for Advanced Therapy Medicinal Products

Published on: Oct 10, 2011 In Europe, advanced therapy medicinal products (ATMPs) are subject to the requirements laid down in the Paediatric Regulation. A company developing an ATMP must, therefore, obtain agreement from the EMA on a paediatric investigation plan (PIP) or waiver prior to submitting its marketing authorisation application (MAA). David Uguen, Cecile de […]

  • Cell &amp
  • Gene Therapy|Regulatory strategy
Whitepaper

Jul 15 2011

Telemedecine and e-Health Systems

Published on: Jul 15, 2011 A long-standing challenge for regulators has been how to incorporate new technologies into the current regulatory framework. This is especially applicable to telemedicine and e-health systems. Sylvie Le Glédic, Marielle Fournier, Sabah Malek

  • Digital Health
Whitepaper

Nov 01 2010

Activities to improve the regulatory framework for companion diagnostics step up

Published on: Nov 1, 2010 Personalised medicine aims to provide the right treatment to the right patient, at the right dose and at the right time. this paper discusses how the regulatory process for companion diagnostics might be improved to realise the potential of personalised medicine. Eric Lawson, Linda Lebon, Anne Virginie Eggimann, Anne Dupraz-PoiseauActivities […]

  • Medical device
Whitepaper

May 05 2010

How to optimally integrate a Paediatric Investigation Plan into a drug development programs

Published on: May 5, 2010 For products falling under the mandatory scope of the centralised procedure, integrating a Paediatric Investigation Plan (PIP) into a company’s development programme can become very challenging.

  • Regulatory strategy
Whitepaper

Apr 26 2010

EU Compassionate Use Programme (CUP) Regulatory Framework and Points to Consider Before CUP Implementation

Published on: Apr 26, 2010 For some patients, compassionate use programmes (CUPs) are the only way to access promising medicinal products that are not yet authorized and for which clinical trials are either not available or in which these patients cannot participate.

  • Clinical Trials
Whitepaper

Jan 05 2010

Overview of the EU CTA Regulatory Framework and Future Direction of the EU Clinical Trial Directive

Published on: Jan 5, 2010 Over the last few years, the European authorities have undertaken substantial new regulatory initiatives regarding the conduct of drug development activities, Clinical Trial Application (CTA) and Marketing Authorisation Application (MAA) submissions.

  • Clinical Trials
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